Open Needle Guide LNGO-2022

GUDID 10813079020421

20/22ga (0.9/0.7mm)

REMINGTON MEDICAL, INC.

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• Primary Device ID: 10813079020421
• NIH Device Record Key: 520fc6a5-116d-4ce6-885f-ac6c16f9c1c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Open Needle Guide
• Version Model Number: LNGO-2022
• Catalog Number: LNGO-2022
• Company DUNS: 788472314
• Company Name: REMINGTON MEDICAL, INC.
• Device Count: 2
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com

Device Dimensions

• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813079020424 [Primary]
GS1	10813079020421 [Package]; Contains: 00813079020424; Package: Inner Carton [10 Units]; In Commercial Distribution
GS1	20813079020428 [Package]; Package: Shipping Carton [10 Units]; In Commercial Distribution
GS1	80813079020420 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983621

FDA Product Code

• IZH: System, x-ray, mammographic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[10813079020421]

Ethylene Oxide

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[10813079020421]

Ethylene Oxide

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Ethylene Oxide

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Ethylene Oxide

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Ethylene Oxide

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Ethylene Oxide

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Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-02
• Device Publish Date: 2020-09-24

Devices Manufactured by REMINGTON MEDICAL, INC.

• 10813079020223 - Bone Marrow "I" Needle: 2020-10-02 15ga (1.8mm) x 1 7/8" (5cm)
• 20813079020237 - Bone Marrow "I" Needle: 2020-10-02 16ga (1.7mm) x 1 7/8" (5cm)
• 10813079020247 - Bone Marrow "J" Needle Double Diamond Tip: 2020-10-02 11ga (3.0mm) x 4in. (10cm)
• 20813079020251 - Bone Marrow "J" Needle Double Diamond Tip: 2020-10-02 11ga (3.0mm) x 6in. (15cm)
• 80813079020260 - Bone Marrow "J" Needle with Double Diamond Tip: 2020-10-02 11ga (3.0mm) x 4in. (10.2cm)
• 20813079020275 - Guidewire Introducer Needle Winged Base Plate: 2020-10-02 18ga (1.3mm) x 7cm
• 20813079020299 - Guidewire Introducer Needle Winged Base Plate: 2020-10-02 19ga (1.1mm) x 7cm
• 20813079020305 - Guidewire Introducer Needle: 2020-10-02 18ga (1.3mm) x 7cm